Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
On July 20, 2017, Merck & Co. announced
that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product reportedly met […]
Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule
regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar […]
The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab)
and Herceptin (trastuzumab)
. Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for […]
On July 12, 2017, Amgen filed a Notice of Withdrawal
of its Motion for Preliminary Injunction. As we previously reported
, Amgen had filed an amended opening brief in support of its motion […]
In an earlier post
, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission. Last week, Bioverativ, which markets the recombinant Factor IX product, […]
On July 6, 2017, Hospira filed a publically available redacted version of its brief
responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported
, following the Supreme Court’s decision in […]
As we’ve posted here
, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization
in the European Union for three biosimilar products: Fulphila (Pegfilgrastim), Ogivri […]
On Wednesday, July 12, 2017, Goodwin’s Elaine Blais will present as a featured speaker during the one-hour webinar, “Who Will ‘Dance’ Now? Biosimilars After Amgen v. Sandoz,”
hosted by the IPO IP Chat Channel. Time: 2:00 […]
Last week, an article
reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and Therapy. Noting […]
On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior art. The Final Written Decisions were issued in